Tag Archives: breast cancer

Cancer Research and Care Embrace Technology

Oncology is about to take a huge step toward changing the way that cancer is understood and treated with the development of a breast cancer-specific prototype for a rapid learning system in cancer care. This system takes advantage of health IT advances (such as EHRs) in order to connect oncology practices, measure quality and performance, and provide physicians with decision support in real time.

The prototype is part of the American Society of Clinical Oncology’s (ASCO’s) vision for CancerLinQ  a “system that assembles and analyzes millions of unconnected medical records in a central knowledge base, which will grow ‘smarter’ over time,” according to the organization.

Illustration courtesy of the American Society of Clinical Oncology

As part of ASCO’s focus on quality improvement, the protoype will use clinical practice guidelines and measures of the Quality Oncology Practice Initiative to build quality measurement and clinical decision tools. Next, breast cancer patient records and data (stripped of identifying information) imported from the electronic health records (EHRs) of academic centers and oncology practices will be added.

As a proof of concept, ASCO says that the prototype will:

  • provide the foundational information and lessons learned to allow ASCO to move into a full-scale implementation;
  • provide real-time, standardized, clinical decision support integration within a demonstration EHR;
  • demonstrate a set of value-added tools; including a physician’s ability to measure their performance against a sub-set of QOPI measures in real-time;
  • demonstrate the ability to capture data from a variety of sources and aggregate the data using novel methodologies;
  • and create a demonstration which will allow exploration of data in unprecedented ways and generate hypotheses related to breast cancer.

Once the full technology platform is completed, CancerLinQ ultimately is expected to improve personalized treatment decisions by capturing patient information in real time at the point of care; provide decision support to cancer teams to adapt treatment plans to each patient and his or her cancer; and report on quality of care, compared with clinical guidelines and the outcomes of other patients. It’s also hoped that the system will help to “educate and empower patients by linking them to their cancer care teams and providing personalized treatment information at their fingertips.” Lastly, the system stands to be a powerful new data source for analysis of real-world quality and comparative effectiveness, as well as to generate new ideas for clinical research. It’s hoped that in time, this approach can be adapted to all types of cancer.

Kerri Wachter

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Should Physicians Prescribe Positivity?

Scott Jordan Harris  is a U.K.-based blogger, editor, book author, movie critic, and sports writer. Remarkable, considering that he spends most of his time in bed. His primary diagnosis is myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome.

In a piece he wrote last week for the BBC’s website, Mr. Harris said that keeping a diary in which he focuses on the positive aspects of his life — at the suggestion of a doctor – keeps him “sane.”

©froglegs/Fotolia.com

“My depression told me my existence was filthy and barren…. After a few months of storing up the previously unrecorded richness of my life, my diary simply disproved that. I knew from re-reading the pages I’d written that I was doing interesting things — and I began to ensure I kept doing them simply to have something to write about. The diary was better than therapy; it pushed me forward through mental pain that had been holding me back.”

He added, “Doctors unaware of the realities of the lives of the chronically ill often suggest we waste what little energy we have noting down exactly how unwell we feel each day, how much we sleep and how little we do, so that they may study the results. These doctors are to be smiled at, and nodded to, and instantly ignored.”

So should physicians advise patients with chronic conditions to keep positive diaries?  I asked two experts.  Dr. Daniel Clauw, a rheumatologist who directs the University of Michigan’s Chronic Pain and Fatigue Research Center, referred me to his associate, Afton Hassett, Psy.D.

“That was a compelling story in the BBC and it actually does reflect my clinical and research experience as a pain psychologist,” Dr. Hassett told me.

Negative and positive affect (emotions) have been well-studied  in health in general and chronic and acute pain states in particular. There are numerous studies suggesting that positive affect plays an important role in pain outcomes. While few formal studies have evaluated the effectiveness of the exact intervention Mr. Harris described, there are studies   supporting the efficacy of similar positive psychology interventions for depression, Dr. Hassett said.

“Enhancing positive affect is likely a good thing for one’s mental and physical health. Sometimes just keeping a gratitude journal like the BBC article writer noted is all it takes. I always tell people to write down three different things each day for which you are grateful. After the first week or so you really start looking for the small wonders in your life: a great cup of coffee, a kind gesture from a complete stranger, the first tiny yellow flowers of spring.”

Courtesy Wikimedia Commons/4028mdk09/Creative Commons License

But Dr. David Spiegel, a psychiatrist who heads the Stanford University Center on Stress and Health, urges caution regarding positive psychology.   “I think the drumbeat for upbeat can be a little overwhelming… I agree with [Mr. Harris] that just focusing on how bad you feel you can dig yourself into a pit, but at the same time you can’t deny your feelings. The worst thing you can do to a depressed person is to tell them to cheer up.”

However, Dr. Spiegel, who works with breast cancer patients, noted that “you can help them by saying let’s give dimension to what’s bothering you, but also put that in perspective, and see other things that are good, that are positive. So it’s not one or the other…Happiness is not the absence of sadness.”

Dr. Spiegel said that advising patients with chronic conditions to keep a diary in general is an “interesting idea,” and that there is a literature base  for the medical benefits of journaling.

He advised that physicians suggest to their patients, “See if it helps you to have a daily journal of your journey through this illness, what your problems were and what your little victories were, and what you did that helped you deal with it and get beyond it.”

—Miriam E. Tucker (@MiriamETucker on Twitter)

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Step Aside, Pink

Courtesy Wikimedia Commons/Jason Meredith/Creative Commons

Raise your hand if you’ve never seen a pink ribbon or don’t know what it means.

No one?

The tremendous success of the pink ribbon breast cancer awareness campaign is a great fundraising and awareness lesson for any charitable organization.  There are no clear numbers on research funds raised by pink ribbons, in part because there are so many sources for pink ribbon items. Still, those ribbons and the public awareness they’ve raised have made a huge difference in breast cancer research and survival. For example, the 5-year breast cancer relative survival rate in 1975-1977 was 75%. In the most recent data from the American Cancer Society’s Cancer Statistics 2011 (table 12), the 5-year breast cancer relative survival rate in 1999-2006 was 90%.

According to the NCI Snapshot of Breast Cancer: “In the United States, breast cancer is the most common non-skin cancer and the second-leading cause of cancer-related death in women. Each year, a small number of men are also diagnosed with or die from breast cancer. Although the rate of diagnosis of breast cancer increased in the 1990s, it has decreased since 2000, and the overall breast cancer death rate has dropped steadily.” In 2008, the incidence rate for breast cancer in white women and African American women is just a tad less than 130 breast cancers per 100,000 women in each group.

The point is this: we’re had incredible success in raising money, awareness and survival for breast cancer. Maybe it’s time to put the same effort into defeating other cancers.

For example, the 5-year relative survival rate for lung/bronchus cancer — represented by a white ribbon, by the way — in 1975-1977 was 13%; in 1999-2006 that rate had increased only to 16%.  Worse still: the 5-year relative survival rate for pancreatic cancer (purple ribbon)  in 1975-1977 was 3%; in 1999-2006 that rate was 6%.

According to the NCI Snapshot of Lung Cancer, lung cancer is the second most common cancer and is the primary cause of cancer-related death in both men and women in the United States. The overall mortality rate for lung and bronchus cancers rose steadily through the 1980s and peaked around 1993. Mortality rates are highest among African-American males, followed by white males.

The button I wear to support my dad's battle against lung cancer. Kerri Wachter/Elsevier Global Medical News

In 2008, the incidence rate of lung cancer among African American men was roughly 100 per 100,000 men; for white men the rate was about 70 per 100,000 men.  Remember though that the 5-year relative lung cancer survival rate in 2006 was estimated at 16%.  That’s a lot of people dying…and that’s just lung cancer. By the way November is the awareness month for lung cancer and stomach cancer (periwinkle ribbon).

The point is, maybe it’s time that the White Ribbon (or purple or gray or … ) became the new Pink Ribbon.
Kerri Wachter

Special thanks to David Sampson, director of medical & scientific communications for the American Cancer Society, for his help with data.

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Quality vs. Quantity: Who’s to Say?

Is quantity of life more valuable than quality of life, and who should be the judge? That seems to be the crux of the dissension between the Food and Drug Administration and the breast cancer guideline panel of the National Comprehensive Cancer Network (NCCN) regarding the use of bevacizumab (Avastin, Genentech) for the treatment of HER2-negative metastatic breast cancer.

In December of last year, the FDA announced that it would be removing the breast cancer indication for the drug, which was initially approved under the agency’s accelerated approval program in 2008 based on promising findings of its use in combination with paclitaxel (Taxol) in the E2100 clinical trial. Following a subsequent review of the trial data and information from additional clinical trials provided by Genentech, the FDA deemed the small increase in progression-free survival in the absence of an overall survival benefit to be outweighed by the risks associated with the drug, and has begun the process of removing the indication.

Although the FDA action would not preclude off-label use of the drug in breast cancer patients, it would effectively prevent it by giving payers a reason not to finance it. As such, Genentech is appealing the decision and appears to have the support of the NCCN, which is retaining bevacizumab in the updated treatment recommendations announced over the weekend at the organization’s annual conference in Hollywood, Florida.

Dr. Robert W. Carlson. Image courtesy of Stanford University.

After multiple “marathon” meetings to discuss the FDA action, the 26-member NCCN breast cancer guideline panel decided unanimously to reaffirm its existing recommendation for bevacizumab in combination with paclitaxel as a therapeutic option for metastatic breast cancer, panel chair Dr. Robert W. Carlson announced at the conference. “The data observed in the [E2100 clinical trial] really had not changed from its approval previously, and we thought, if the data were compelling 2 years ago, why isn’t it compelling enough today?”

A revised footnote accompanies the panel’s recommendation: “Randomized clinical trials in metastatic breast cancer document that the addition of bevacizumab to some first- or second-line chemotherapy agents modestly improves time to progression and response rates but does not improve overall survival. The time-to-progression impact may vary among cytotoxic agents and appears greatest with bevacizumab in combination with weekly paclitaxel.”

Dr. Carlson, of Stanford University (Palo Alto, CA) was not dismissive of the toxicities associated with bevacizumab, but reiterated the panel sentiment that the progression-free survival benefit is a quality of life measure that should not be overlooked. “Progression-free survival is an important end point in the adjuvant setting. If it means the difference between 5 months with the disease under control vs. 5 months of disease progression, there is value in that.”

Dr. Carlson disclosed receiving grant and research support from AstraZeneca Pharmaceuticals LP, Genentech, Inc., Pfizer Inc., and Sanofi-aventis US.

—Diana Mahoney

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Breast Cancer Research: Forgetting the Patients?

At the San Antonio Breast Cancer Symposium, Dr. Thomas B. Julian (Allegheny General Hospital in Pittsburgh) presented results from the NSABP B-32 trial.  In that study 5,611 breast cancer patients with clinically negative axillary lymph nodes were randomized to receive sentinel lymph node (SLN) biopsy followed by axillary lymph node dissection (ALND), or SLN biopsy followed by ALND — only if the SLN biopsy was positive.

Photo by K. Wachter

The researchers found that the size of SLN metastasis was an independent predictor of disease-free survival and overall survival on multivariate analysis, along with histologic grade, age, clinical tumor size, number of positive axillary nodes, and adjuvant therapy.

At the end of his presentation, Dr. Julian noted that a paper based on a B-32 substudy on whether isolated tumor cells and micrometastases affect patient outcomes will appear in an upcoming issue of the New England Journal of Medicine.

This happens a lot at medical meetings. Some data are presented, but some are also reserved for publication. After the presentation, a session moderator asked if it was safe to assume that because H&E-detected micrometastases did not result in worse survival than node-negative disease that the same would be true for the immuno-detected micrometastases.

Dr. Julian’s answer: “One could assume that, but you have to wait for the paper.” Again, I hear this a lot at medical meetings, and I didn’t think too much about it.

Image courtesy of Flickr user Fotos Gov/Ba (CC).

That was until a patient advocate worked up the nerve later in the session to take Dr. Julian and the research establishment to task for the way that medical research findings are typically doled out. 

“I had to get up the courage to do this, but I was really offended by the last reporter, who refused to tell us the results of the study because of his need to keep it quiet for publication,” she told the audience of several thousand. “I really think this is a disservice, and it’s a symptom of what’s wrong with the research establishment. It’s something that advocates want to change … If we change the research system and not make it so dependent on careers, on money, on publications, we might be able to make more progress.”

She’s right.  Presenters at big medical meetings often think in terms of data, forgetting that they’re really talking about patients.  Maybe there’s no harm in waiting a couple of months to present that data, but there’s also a chance that the data could change clinical practice — that they could extend or save a life. 

I’m not a physician, but I don’t think that’s a chance that I would want to take, if I were.  It’s definitely not a risk I want to take as a patient.

Let us know what you think.

Kerri Wachter (on Twitter @knwachter)

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Video of the Week: Zoledronic Acid & What the Headlines Got Wrong

One of the bigger news items to come out of last week’s San Antonio Breast Cancer Symposium was the long-awaited primary efficacy end-point analysis from the AZURE trial (Does Adjuvant Zoledronic acid redUce REcurrence in patients with high-risk localised breast cancer?).

Yes, the study did fail to meet the primary end-point of improved disease-free survival (DFS) in all women in the study group (women with stage II or III breast cancer at high risk of relapse). But the addition of zoledronic acid to neoadjuvant or adjuvant chemotherapy and/or hormonal therapy did signficantly improve survival in postmenopausal women. In a planned subanalysis, the researchers found that women who had undergone menopause at least 5 years earlier had a significant 29% improvement in overall survival.

This finding appears to be consistent with improved survival seen in the ABCSG-12 trial, among premenopausal women on medication to suppress ovarian function — and reduce estrogen levels. Estrogen levels also decline with menopause. This could be good news for a big portion of breast cancer patients. Dr. Robert Coleman, lead author of the AZURE study, noted that more than half of breast cancer patients are postmenopausal.

Dr. Coleman — and ABCSG-12 lead author Dr. Michael Gnant — talked with our reporter Kerri Wachter about what the AZURE results really mean.

Read the story at Internal Medicine News and check out more news from SABCS.

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Video of the Week: Mammography Screening in Women 40-49 Years

Dr. Jennifer Obel told our reporter Kerri Wachter that real-world results of screening mammography in women aged 40-49 years – from the Swedish SCRY Study (mammography SCReening of Young women) – provide more data for clinicians to discuss with their patients.

New data from the large Swedish cohort suggest that screening mammography in women aged 40-49 years reduced the risk of breast cancer mortality by 26%, compared with women in that age group who were not screened. The results were presented at the the annual Breast Cancer Symposium sponsored by the American Society of Clinical Oncology.

It’s widely accepted that screening mammography significantly reduces mortality in women aged 50-69 years, but the effectiveness of screening in women aged 40-49 years has been less clear.

To read more about the results, check out the story at the Internal Medicine News website, along with the latest medical news.

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Genomic Sequencing: Where Science and Law Collide

Have law and policy ever been able to keep up with scientific discovery and innovation?  When some hominid first discovered how to ignite a fire, there was probably a lawyer on hand to extinguish it because it infringed on an ingenious technique for using a couple of sticks to make smoke.

Microarray (gene chip), image courtesy of NHGRI

Eons later, we haven’t made much progress in keeping our legal system in pace with the exponential advances of science and technology.  Even as our courts are addressing the vexing question of whether specific genes — and the analysis of those genes — can be patented, the ability to commercially sequence an individual’s whole genome is rapidly advancing.

I had a chance to talk with Dr. Lynn Jorde, who is president-elect of the American Society of Human Genetics, at the society’s annual meeting.  He pointed out to me that Myriad Genetics‘ patent of BRCA1/2 genes prevents all uses of the information that the genes contain. Essentially, if a a physician or geneticist has knowledge of a BRCA mutation that puts a patient at increased risk of breast and ovarian cancer, he or she can not disclose this information under the patent.

If the Myriad test is the only way to determine the presence of such mutations — forgetting the issue of second opinions — maybe it’s not such a big deal.  Suppose, however, that the patient’s whole genome has been sequenced … from which one could “see” the presence of the mutations.  Under the law, a physician can’t make a diagnosis, tell the patient or start the patient on treatment.  As ASHG wrote in its amicus brief in the Myriad case:

By staking claims on all isolated versions of the BRCA1 and BRCA2 genes, Myriad effectively controls all of the naturally occurring BRCA1 and BRCA2 breast cancer genes from everyone‘s bodies. No woman (or man) can give her (or his) own breast cancer gene to a doctor or researcher to analyze for purposes of diagnosis or research, because once that gene is removed from the body Myriad‘s patent claims cover it. No clinician or scientist can perform diagnosis or research using such gene sequences or the information they contain without violating the patents.

Yet every physician essentially takes an oath to treat disease and illness … not to mention sharing medical research.  Talk about caught between a rock and a hard place.

Of course, personal genomic sequencing is still a ways off for most people, Ozzy Osbourne notwithstanding. For now, Myriad’s patents for BRCA1/2 are invalidated but that court decision is under appeal.  At the end of October, the New York Times reported that the U.S. Department of Justice has weighed in on the decision by filing an amicus brief that essentially supports the idea that genes are not patentable. Only time will tell how things will shake out in this case … or what it will mean for many other gene patents on file at the USPTO.

Ironically, Dr. Jorde — who got me thinking about all of this — works for the University of Utah, Salt Lake City, a joint plaintiff with Myriad, in the case.

Kerri Wachter

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Not Just Surviving: More Cancer Doctors Tune in To Patients’ Post-Treatment Lives

The 2010 Breast Cancer Symposium, held last week in National Harbor, Md., dedicated an entire session to survivorship. The specific topics included sexuality, survivorship in older patients, management of osteonecrosis of the jaw, and physical activity, diet, and weight.  

courtesy of flickr user N!els (creative commons)

This is encouraging. It seems like more doctors are paying increasing attention to the quality of cancer patients’ lives after their treatments are over. Dr. Michael Krychman of Newport Beach, Calif., emphasized the importance of individualizing sexual problems in cancer survivors. The decrease in estrogen after cancer treatment can cause a range of sexual problems for which there are a range of solutions even at the most basic level, such as choosing the right lubricant for vaginal dryness, he said.

 

 

The physical activity talk stood out in light of recent guidelines issued by the American College of Sports Medicine (ACSM). Dr. Rachel Ballard-Barbash of the National Cancer Institute mentioned the guidelines and emphasized the value of a variety of types of exercise—cardiovascular activity, resistance training, and flexibility—for cancer survivors.

My colleague Kerri Wachter (@knwachter on Twitter), covered the ACSM’s June meeting, and blogged about how the recommendations said that there’s no reason why cancer patients can’t get out and do whatever exercise feels good to them. Kerri also conducted a video interview with Kathryn Schmitz, Ph.D., of the University of Pennsylvania, lead author on the ACSM guidelines.

Dr. Ballard-Barbash said that even though studies of exercise interventions for cancer patients haven’t shown significant weight loss, they have shown improvements in cardiovascular fitness and physical function. And let’s not underestimate the psychological benefits of exercise in general, and the comfort and joy of returning to a favorite activity in particular.

–Heidi Splete (@hsplete on twitter)

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BRCA1: A Race Still Not Finished

All the talk over the past couple of days about the patentability of the BRCA1 gene got me thinking about the heady, headline-making days 16 years ago when the story began, a story of a multi-year race to claim a gene.

It was September 1994 that researchers from the University of Utah and Myriad Genetics announced that they had cloned and sequenced the BRCA1 gene. Their paper appeared in the Oct. 7, 1994, issue of Science, but according to an account in the Sept. 15 issue of The New York Times by Natalie Angier, the embargo had broken via a television news report (a quaint footnote of its own, a time when news still broke on TV).

Angier’s write up describes the BRCA1 gene as a “ferociously coveted” “genetic trophy,” and the culmination of an “international, race.” An editorial on the news from the October 1994 issue of Nature Genetics called it “the glittering prize.”

Angier quoted the leader of the 45-member Utah/Myriad research team, geneticist Dr. Mark Skolnick, as saying that it felt “very, very good” to have captured the gene. The Times’ article also cited the gracious loser of the race, Mary-Claire King. Ph.D., then at the University of California at Berkeley, now at the University of Washington, who had these kind words for her rivals: ” This is beautiful work…these guys deserve their success.”

image courtesy National Library of Medicine

Dr. King began pursuing breast cancer genes in the late 1970s, had narrowed down the search to human chromosome 17 in 1990, and had a key role in coining the BRCA designation a year later. (She said it was in part inspired by Paul Broca, a 19th century French pathologist who pioneered recognition of breast cancer pedigrees.)

I recall seeing her walk to the podium to give a talk at the annual meeting of the American Society of Human Genetics in Montreal in October 1994, just after the Myraid paper came out. She received a standing ovation from the large, packed audience, and began by saying that she was okay with the outcome, with the fact that the guys from Utah had beaten her to the gene.

Now, 16 years later, the news is that the prize may not have been so commercially glittering after all.

—Mitchel Zoler (on Twitter @mitchelzoler)

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